Registration Dossier
Registration Dossier
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EC number: 207-987-9 | CAS number: 504-24-5
Endpoint summary
Administrative data
Description of key information
As recommended in the ECHA Guidance we have performed threein- vitro and in- chemico tests on skin sensitisation covering the key events of adverse outcome pathway (AOP):
1.) Direct Peptide Reactivity Assay (DPRA)
In this guideline study under GLP conditions, the test item showed minimal reactivity towards bothpeptides.The test item is considered as non-sensitiser in the DPRA.
2.) ARE-Nrf2 Luciferase Test Method (KeratinoSens™)
In this guideline study under GLP conditions, the test itemdid not induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered asnonsensitiser in the KeratinoSens™.
3.) Human Cell Line Activation Test (h-CLAT)
In this guideline study under GLP conditions,the test item did upregulate the cell surface markers in at least two independent experiment runs. Therefore, the test item is considered to be a skin sensitiser in the h-CLAT in accordance with UN GHS category 1.
For details, please see study summary.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Due to the AOP-based “two out of three” skin sensitization integrated testing strategy (ITS) for hazard identification we classify the substance as “non sensitiser” since the DRPA and KeratinoSens™ study were negative.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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